Nocturnal Insulin-Glucose in Hospital: Tight Control

Corporacion Parc Tauli1 site in 1 country12 target enrollmentJanuary 2014

ConditionsType 1 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Corporacion Parc Tauli
Enrollment: 12
Locations: 1
Primary Endpoint: Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

December 2017

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Corporacion Parc Tauli

Responsible Party

Principal Investigator

Mercedes Rigla

MD, PhD

Corporacion Parc Tauli

Eligibility Criteria

Inclusion Criteria

•Type 1 Diabetes
•Diabetes duration \> 3 years
•Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year
•No ketoacidosis during the previous 12 months
•Glomerular Filtration Rate (GFR) \> 60 ml/kg/min m2
•Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice